Schedule H

Intravenous

Form Strength

Injection 600 mg per vial (ceftaroline fosamil powder for reconstitution)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

▶ Community-Acquired Bacterial Pneumonia (CABP)

Parameter Details

Starting dose 600 mg IV every 12 hours

Titration Not applicable

Usual maintenance dose 600 mg IV every 12 hours

Maximum dose 600 mg IV every 8 hours (severe infections, specialist discretion)

Duration 5–7 days based on clinical response

Infusion time Over 5–60 minutes

Key Clinical Notes:

• Active against penicillin-resistant and multidrug-resistant Streptococcus pneumoniae

• Reserve for cases where standard beta-lactams are unsuitable or resistance documented

▶ Acute Bacterial Skin and Skin Structure Infections (ABSSSI) — including MRSA

Parameter Details

Starting dose 600 mg IV every 12 hours

Titration Not applicable

Usual maintenance dose 600 mg IV every 12 hours

Maximum dose 600 mg IV every 8 hours (severe/deep-seated infections)

Duration 5–14 days depending on severity and clinical response

Infusion time Over 5–60 minutes

Key Clinical Notes:

• One of few cephalosporins with reliable MRSA activity

• Consider when vancomycin/linezolid not suitable or failed

Secondary Indications – Adults Only (Off-label):

▶ Bacteraemia associated with MRSA or Drug-Resistant S. pneumoniae — OFF-LABEL

Parameter Details

Starting dose 600 mg IV every 8 hours

Titration Not applicable

Usual maintenance dose 600 mg IV every 8 hours

Maximum dose 600 mg IV every 8 hours

Duration 10–14 days (source-dependent)

Supervision Specialist only

Evidence basis Observational data; salvage therapy in international RCTs

▶ Bone and Joint Infections due to MRSA — OFF-LABEL

Parameter Details

Starting dose 600 mg IV every 8 hours

Titration Not applicable

Usual maintenance dose 600 mg IV every 8 hours

Maximum dose 600 mg IV every 8 hours

Duration ≥4–6 weeks (often with surgical debridement)

Supervision Specialist only

Evidence basis Supportive observational evidence; Indian tertiary centre experience

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

• Community-Acquired Bacterial Pneumonia (≥2 months)

• ABSSSI including MRSA (≥2 months)

2 months to <2 years 8 mg/kg IV every 8 hours Not applicable 8 mg/kg IV every 8 hours 600 mg/dose Infuse over 60 minutes

2 to <12 years 12 mg/kg IV every 8 hours Not applicable 12 mg/kg IV every 8 hours 600 mg/dose Monitor renal function

12 to 18 years 600 mg IV every 12 hours Not applicable 600 mg IV every 12 hours 600 mg every 8 hours (severe) Adult dosing; renal adjustment if required

Safety Monitoring:

• Baseline and periodic CBC (neutropenia risk with prolonged use)

• Renal function monitoring in all age groups

• Watch for diarrhoea and hypersensitivity reactions

Minimum Age: 2 months

Secondary Indications – Paediatrics (Off-label):

Not established in India; use limited to approved indications pending further paediatric safety data.

Age Restriction Statement:

Not recommended below 2 months of age. Use in children should be under infectious disease specialist supervision.

Note: Ceftaroline is dialyzable; schedule doses post-dialysis on dialysis days.

• Known hypersensitivity to ceftaroline fosamil or any component of formulation

• Documented severe hypersensitivity (anaphylaxis, angioedema) to any cephalosporin

• History of severe immediate hypersensitivity reaction to penicillins or carbapenems

• History of non-severe penicillin allergy (cross-reactivity possible; use with monitoring)

• Prior history of seizure disorder — beta-lactams may lower seizure threshold

• Pre-existing renal impairment — dose adjustment required; risk of drug accumulation

• Prolonged therapy (>14 days) — increased risk of neutropenia and Clostridioides difficile infection

• No activity against Pseudomonas, ESBL-producers, Acinetobacter, or anaerobes — not suitable for these pathogens

Parameter Recommendation

Risk category Not formally classified in India; limited human data

Overall safety Use only if benefit clearly outweighs risk

Preferred alternatives Ceftriaxone for routine Gram-positive infections in pregnancy

When may be used MRSA infections where alternatives unsuitable; specialist decision

Monitoring Maternal renal function; fetal growth surveillance if prolonged use

Parameter Recommendation

Excretion in milk Expected to be low (based on class pharmacokinetics)

Compatibility Likely compatible; no adverse neonatal effects reported

Preferred alternatives Other cephalosporins (cefazolin, ceftriaxone) unless MRSA coverage specifically required

Infant monitoring Diarrhoea, oral candidiasis, rash, feeding difficulties

Parameter Recommendation

Starting dose Same as adult (600 mg IV every 12 hours) unless renal impairment present

Titration Not applicable

Additional risks Age-related decline in renal function; increased risk of drug accumulation

Special considerations Check baseline eGFR and adjust dose accordingly; monitor for CNS effects and neutropenia

Interacting Drug/Class Mechanism / Risk Recommendation

Aminoglycosides (gentamicin, amikacin) Additive nephrotoxicity Avoid combination if possible; if essential, monitor renal function closely

Amphotericin B Additive nephrotoxicity Avoid concurrent use; monitor renal function if unavoidable

Other beta-lactams (high-dose) Additive CNS toxicity (seizure risk) especially in renal impairment Use caution; avoid unnecessary combinations

Interacting Drug/Class Mechanism / Risk Recommendation

Probenecid Reduces renal tubular secretion; may increase ceftaroline levels Avoid co-administration or monitor for toxicity

Warfarin No direct pharmacokinetic interaction; infection/antibiotic effect may alter INR Monitor INR during and after ceftaroline therapy

Loop diuretics (furosemide) Potential additive nephrotoxicity in high-risk patients Monitor renal function

Live vaccines Theoretical reduced immunogenicity during acute infection Defer vaccination until infection resolved

• Diarrhoea

• Nausea

• Rash

• Headache

• Pruritus

• Mild elevation of hepatic transaminases

• Hypokalaemia

• Positive direct Coombs test (without haemolysis)

Adverse Effect Notes

Anaphylaxis / severe hypersensitivity Requires immediate discontinuation and emergency management

Clostridioides difficile-associated diarrhoea (CDAD) May occur during or after therapy; discontinue and initiate specific treatment

Neutropenia Particularly with duration >14 days; reversible on discontinuation

Seizures Rare; dose-related; more likely in renal impairment or CNS disorders

Haemolytic anaemia (Coombs-positive) Rare; monitor if prolonged therapy

During therapy (short course <7 days) Clinical response; watch for hypersensitivity, GI symptoms

During therapy (>7 days) CBC every 5–7 days (neutropenia risk); renal function every 3–5 days

Prolonged therapy (>14 days) Weekly CBC mandatory; monitor for neuropathy signs, CDAD symptoms

Post-therapy Assess for delayed hypersensitivity; GI symptoms; resolution of infection markers

Timing Parameters

Baseline CBC with differential, serum creatinine/eGFR, LFTs, culture and sensitivity

During therapy (short course <7 days) Clinical response; watch for hypersensitivity, GI symptoms

During therapy (>7 days) CBC every 5–7 days (neutropenia risk); renal function every 3–5 days

Prolonged therapy (>14 days) Weekly CBC mandatory; monitor for neuropathy signs, CDAD symptoms

Post-therapy Assess for delayed hypersensitivity; GI symptoms; resolution of infection markers

NLEM Status: Not included in NLEM 2022; not under price control

Government Supply: Available sporadically under tertiary care hospital procurement

• Unique among cephalosporins for reliable MRSA and drug-resistant S. pneumoniae activity — reserve for confirmed resistant infections

• Does NOT cover Pseudomonas, ESBL-producers, Acinetobacter, or anaerobes — inappropriate for hospital-acquired Gram-negative infections

• Use q8h regimen (off-label high-dose) for bacteraemia and deep-seated MRSA infections under specialist guidance

• Neutropenia risk increases significantly after 14 days — mandatory weekly CBC monitoring for prolonged courses

• Ceftaroline fosamil is a prodrug; ensure proper reconstitution and infusion technique

• Consider step-down to oral agents (e.g., linezolid for MRSA) once clinical improvement documented

ceftaroline; cephalosporin; fifth-generation; MRSA; CABP; ABSSSI; skin infection; pneumonia; IV antibiotic; renal-adjust; neutropenia-risk

RxIndia v1.0 — 28 May 2025

• CDSCO approved formulation list

• Indian Pharmacopoeia 2018 (and updates)

• AIIMS Antimicrobial Policy 2023

• ICMR Treatment Guidelines for Antimicrobial Use 2022

• API Textbook of Medicine, 11th edition

• Harrison's Principles of Internal Medicine, 21st edition

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian tertiary hospital antimicrobial stewardship protocols

• International RCTs (for off-label indications only — clearly marked)